Diabetic Foot UlcersPhase 1/2NCT00316537
Safety and Preliminary Efficacy Study of Nicotine Gel to Treat Diabetic Foot Ulcers
A Phase 1/2 study testing ATG002 (study drug) in people with Diabetic Foot Ulcers, run by CoMentis at 13 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and preliminary efficacy of low dose nicotine gel in patients with chronic diabetic ulcers Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- ATG002 (study drug)
- How many people
- 48 participants
- Where
- 13 sitesUnited States
- Study dates
- Oct 2006to Jul 2007
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diabetes mellitus type II
- Single non-healing uninfected partial or full-thickness foot ulcer secondary to diabetic neuropathy, in the absence of significant peripheral arterial disease.
Who cannot join
- Patients who use tobacco in any form or who are on nicotine replacement therapy
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Center for Clinical Research
Castro Valley, California, 94546
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
SeniorCare, Alabama Geriatric Specialists
Homewood, Alabama, 35209
Ankle and Foot Specialists of Atlanta
Lithonia, Georgia, 30058
University of Miami
Miami, Florida, 33136
Aurora Health Care / Lukes Medical Center
Milwaukee, Wisconsin, 53215
Crossroads Research, Inc.
Owings Mills, Maryland, 21117
Hope Research Institute
Phoenix, Arizona, 85050
University of San Diego Wound Treatment and Research Center
San Diego, California, 92103
Southern Arizona VA Health Care System
Tucson, Arizona, 85723
NewBridge Medical Research
Warren, Pennsylvania, 16365
Central Washington Podiatry Service
Yakima, Washington, 98902
About this study
Official title: A Multicenter, Randomized Study of the Safety and Preliminary Efficacy of Low-Dose Nicotine Gel (ATG002) in Patients With Plantar Diabetic Foot Ulcers
The purpose of this study is to evaluate the safety and preliminary efficacy of low dose nicotine gel in patients with chronic diabetic ulcers
Read the detailed description
This pilot study will be the first time that nicotine will be applied directly onto the surface of chronic diabetic ulcer. The goals of the study are to evaluate safety and tolerability (particularly at the wound site) of a gel formulation containing low-dose nicotine, and to obtain preliminary information on its effects on accelerating wound closure. The study will be carried out on a background of conventional wound therapy in patients with Type II diabetes mellitus. Patients will be randomized to receive either study medication (ATG002), vehicle gel, or standard-of-care.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- ATG002 (study drug)
- Keywords
- diabetes, foot ulcers, nicotine gel, wound healing
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATG002 (study drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of ulcer size as determined by weekly ulcer tracings
Secondary outcomes (1)
Assessment for complete wound closure. "Complete wound closure" will be defined as full epithelialization of the wound with the absence of drainage and lack of dressing requirement for an interval of at least 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2006 (estimated)
- Study startOct 2006
- Study completionJul 2007
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CoMentis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Henry Hsu, MD, Study director, Athenagen, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316537
- Sponsor's protocol ID
- ATG002-121
- Status last verified
- Aug 2007
- First submitted
- 17 Apr 2006
- Last updated
- 9 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Study of the Safety and Preliminary Efficacy of Low-Dose Nicotine Gel (ATG002) in Patients With Plantar Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT00316537
- Acronym / sponsor ID
- ATG002-121
- Conditions
- Diabetic Foot Ulcers
- Keywords
- diabetes, foot ulcers, nicotine gel, wound healing
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- CoMentisIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Study completion
- Jul 2007 (actual)
- First posted
- 21 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and preliminary efficacy of low dose nicotine gel in patients with chronic diabetic ulcers
Detailed description
This pilot study will be the first time that nicotine will be applied directly onto the surface of chronic diabetic ulcer. The goals of the study are to evaluate safety and tolerability (particularly at the wound site) of a gel formulation containing low-dose nicotine, and to obtain preliminary information on its effects on accelerating wound closure. The study will be carried out on a background of conventional wound therapy in patients with Type II diabetes mellitus. Patients will be randomized to receive either study medication (ATG002), vehicle gel, or standard-of-care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with diabetes mellitus type II
- Single non-healing uninfected partial or full-thickness foot ulcer secondary to diabetic neuropathy, in the absence of significant peripheral arterial disease.
Key exclusion criteria (1 listed)
- Patients who use tobacco in any form or who are on nicotine replacement therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATG002 (study drug) | Drug | – |
Primary outcome
Assessment of ulcer size as determined by weekly ulcer tracings
1 secondary outcome
Assessment for complete wound closure. "Complete wound closure" will be defined as full epithelialization of the wound with the absence of drainage and lack of dressing requirement for an interval of at least 2 weeks.
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2007.
Related trials for Diabetic Foot Ulcers
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry Hsu, MD study director
Athenagen, Inc.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ATG002 (study drug) in people with Diabetic Foot Ulcers, run by CoMentis at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of ulcer size as determined by weekly ulcer tracings. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2007.